Pfenex regains rights to Lucentis biosimilar, reports data

Pfenex Inc. (NYSE-M:PFNX) regained worldwide rights to PF582 and said the biosimilar of Lucentis ranibizumab met the primary endpoint of demonstrating similar safety and tolerability to its reference product in a Phase I/II study to treat wet age-related macular degeneration (AMD). Pfizer Inc. (NYSE:PFE) returned rights to PF582 following a "strategic review of the current therapeutic focus of its biosimilar pipeline," the biotech said.

Pfenex said there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis, and no imbalances in local or systemic adverse events in the three-month study. The biotech said the biosimilar's pharmacological activity was "consistent" with its reference product, and that antidrug antibody findings were comparable for the two. Additionally, Pfenex said there were no meaningful differences in best corrected visual acuity or decreases in central retinal thickness. ...